Intraoperative Stereovision for Surgical Guidance

术中立体视觉用于手术指导

• 批准号: 10482607
• 负责人: DAVID W ROBERTS
• 金额: $ 91.47万
• 依托单位: INSIGHT SURGICAL TECHNOLOGIES, LLC
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-01 至 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10482607
• 关键词: 3-Dimensional; Algorithms; Animals; Automation; Brain; Brain Neoplasms; Calibration; Clinical; Code; Computer software; Data; Data Collection; Diagnosis; Entrepreneurship; Excision; Family suidae; Flowcharts; Foundations; Funding; Future; Glioma; Image; Image-Guided Surgery; Incentives; Intellectual Property; Laboratories; Legal patent; Magnetic Resonance Imaging; Malignant neoplasm of brain; Meta-Analysis; Modeling; Multi-site clinical study; Navigation System; Operative Surgical Procedures; Patient-Focused Outcomes; Patients; Performance; Phase; Policies; Procedures; Progress Reports; Progression-Free Survivals; Research; Resected; Risk; Scanning; Site; Software Validation; Speed; Surface; Surgeon; Surveys; System; Technology; Testing; Time; United States National Institutes of Health; Update; Validation; animal data; base; brain tumor resection; career; clinical research site; clinically relevant; commercialization; data acquisition; design; image guided; improved; in vivo; innovation; insight; member; mortality; neurosurgery; pre-clinical; prospective; reconstruction; software systems; verification and validation

PROJECT SUMMARY/ABSTRACT: InSight Surgical Technologies, LLC, is a start-up founded by senior members of a long-standing NIH-funded research effort to develop intraoperative image updating that maintains accurate image correspondence with the surgical field throughout a procedure. The effort has led to research innovations that have generated an intellectual property (IP) portfolio of 13 issued and 8 pending patents. Phase I demonstrated feasibility of new algorithms for assembling multiple intraoperative stereovision (iSV) acquisitions into a composite field-of-view and accomplishing iSV-to-MRI registration/re-registration, and conversion of existing iSV algorithms for 3D surface reconstruction and calibration in graphics processing unit (GPU) accelerated forms. Additionally, Phase I results obtained during resection of a large animal (swine) brain tumor indicate this model is a superb system for testing and validating InSight’s complete image updating system, I2UpdateTM, in vivo in Phase II. Specifically, we will leverage Phase I results to automate I2UpdateTM fully, and demonstrate its technical performance and clinical functionality under quality systems sufficient to meet regulatory requirements. Specific aims will (i) develop a fully-automated, GPU-enabled processing system for intraoperative image-updating (I2UpdateTM), (ii) complete verification testing and pre-clinical in vivo validation of I2UpdateTM, under quality system controls sufficient for supporting regulatory filings at the end of Phase II, and (iii) conduct a multi-site clinical-use study with I2UpdateTM under non-significant risk in patients undergoing brain tumor resection. Successful completion of Phase II will produce the I2UpdateTM product platform as a finalized commercial GPU-enabled software system with concomitant design control, software validation, procedural use and quality systems, accompanied by in vivo animal validation and multi-site, multi-surgeon use demonstrating clinically- relevant and acceptable image-updating performance in terms of automation, computational efficiency and registration accuracy.

项目摘要/摘要： Insight Surgical Technologies，LLC是一家由NIH资助的高级成员创立的初创公司 开发术中图像更新的研究工作，以保持与准确的图像对应关系 整个过程中的手术场。这项努力导致了研究创新 知识产权（IP）13张发行的投资组合和8份申请专利。第一阶段证明了新的可行性 用于组装多个术中立体电视（ISV）采集到复合视野的算法 并完成ISV到MRI注册/重新注册，以及3D现有ISV算法的转换 图形处理单元（GPU）加速形式中的表面重建和校准。此外， 在切除大型动物（猪）脑肿瘤期间获得的第一阶段结果，表明该模型是一个极好的 测试和验证Insight完整图像更新系统I2UPDATETM的系统，II阶段。 具体来说，我们将利用I阶段结果充分自动化I2UpDatetm，并证明其技术 质量系统下的性能和临床功能足以满足监管要求。具体的 AIMS将（i）开发一个完全自动化的，启用GPU的处理系统，用于术中图像升级 （i2updatetm），（ii）在质量下完成I2UPDATETM的完整验证测试和临床前体内验证 系统控制足以在II阶段结束时支持监管档案，并且（iii）进行多站点 在接受脑肿瘤切除的患者中，对I2UPDATETM进行I2UPDATETM的临床使用研究。 成功完成第二阶段将生产I2UPDATETM产品平台作为最终商业广告 具有GPU的软件系统具有伴随的设计控制，软件验证，程序使用和质量 系统，伴随着体内动物验证和多站点的多部门使用，表明在临床上证明 在自动化，计算效率和 注册准确性。